Colon Cancer Diagnosis With FAPI-PET Imaging
ConditionColon Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorTurku University Hospital
About this trial
Whole body CT is the primary imaging method in staging and follow-up of colon cancer. Conventional PET-CT with 18F-labeled fluorodeoxyglucose (18F-FDG) has its limitations and has a secondary role in colon cancer protocols. A new PET tracer, fibroblast activation protein inhibitor (FAPI), targeting a protein that is overexpressed by cancer-associated fibroblasts presents a potential new PET imaging tool.
The objective of this prospective study is to evaluate diagnostic efficacy of 18F-FAPI-74 PET/CT in patients with colon cancer. The aim is to evaluate the sensitivity and specificity of 18F-FAPI-74 in detection of local lymph node metastasis and distant metastasis in patient level in patients with colon cancer in primary staging and when suspected recurrence. 100 patients with colon cancer are enrolled and PET/CT studies are performed with the novel 18F-FAPI-74 tracer. The data will be collected between 2024-2026.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with primary colon cancer with suspicion of mesenteric lymph node metastases in computed tomography before primary cancer operation
Patients with primary colon cancer with potentially curable metastases
Patients with suspected metastasis or local recurrence in computed tomography and/or elevated carcinoembryonic antigen (CEA) in cancer surveillance
WHO performance score 0-2
Disqualifiers
Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included
Patient is not able to understand purpose of study
Medical conditions prohibiting whole body PET-CT
Trial design
Design model
Single group
Treatments tested in this trial
PET/CT ([F-18]FAPI-74)
DevicePET/CT with FAPI-74 tracer is performed
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: StagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
1) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis in patient level in patients with primary colon cancer
Time frame
2 years2
2) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of distant metastasis in patient level in patients with primary colon cancer
Time frame
2 years3
3) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph metastasis and distant metastasis in patient level in patients with recurrent colon cancer
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov